Yoga and Aerobic Exercise Training in Primary Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

Comparison of the Effects of Yoga and Aerobic Exercise Training in Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05623085
• Other study ID #: KA- 21091
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effects of aerobic exercise and yoga exercises on menstrual pain parameters (pain severity and duration, analgesic usage), uterine artery blood flow, menstrual stress level, physical fitness, anxiety/depressive symptom level, quality of life and sleep quality in individuals with primary dysmenorrhea. This study is a prospective, parallel group, randomized study. Three days a week for eight weeks, the participants in this study will receive individualized yoga and aerobic exercise.

In the literature, there are no studies comparing the effectiveness of aerobic exercise and yoga in the management of PD, which is a public health problem that seriously affects women's lives. Especially when aerobic exercise and yoga exercises are considered, there is no study on how much the features such as uterine artery blood flow and physical fitness sub-parameters have changed with these two commonly used exercise types separately in the management of PD.

Description:

The aim of this study is to compare the effects of aerobic exercise and yoga exercises on menstrual pain parameters (pain severity and duration, analgesic usage), uterine artery blood flow, menstrual stress level, physical fitness, anxiety/depressive symptom level, quality of life and sleep quality in individuals with primary dysmenorrhea. This study is a prospective, parallel group, randomized study.

It was planned to enroll 44 individuals with Primary Dysmenorrhea in this randomized study. A physical therapist is responsible for all assessments.

Participants were included in one of two treatment groups (G1: Aerobic exercise; G2: Yoga exercise).

In the literature, there are no studies comparing the effectiveness of aerobic exercise and yoga in the management of PD, which is a public health problem that seriously affects women's lives. Especially when aerobic exercise and yoga exercises are considered, there is no study on how much the features such as uterine artery blood flow and physical fitness sub-parameters have changed with these two commonly used exercise types separately in the management of PD.

The results of our study show that norm values can be established by evaluating uterine arterial blood flow and physical fitness, instead of focusing on pharmacological treatment and classical nonpharmacological approaches (warm application, transcutaneous electrical nerve stimulation (TENS), acupuncture, etc.) in individuals with PD. It is aimed to develop new exercise protocols that can be done easily. It is expected that our results, which we will obtain in the light of the original values of our research, will contribute to the literature and guide future studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals who do not have any known disease (systemic, metabolic, etc.),

• No complaints of acute or chronic pain other than dysmenorrhea,

• Meeting the primary dysmenorrhea criteria outlined in the Primary Dysmenorrhea Consensus Guide (onset of menstrual pain 6-24 months after menarche, menstrual pain lasting 8-72 hours, and the most severe pain felt on the 1st or 2nd day of menstruation),

• Have a regular menstrual cycle (28± 7 days),

• The severity of menstrual pain in the last 6 months is = 4 cm according to the Visual Analogue Scale,

• 18 years and over,

• Nulligravid (unborn)

• Volunteer female individuals who gave consent to participate in the study

Exclusion Criteria:

• Individuals undergoing pelvic surgery,

• Having a history and/or finding of secondary dysmenorrhea,

• Receiving alternative treatment,

• Using intrauterine contraceptive device or birth control pill,

• Individuals with situations where exercise is contraindicated (answering yes to any of the 7 questions on the exercise readiness scale),

• Not complying with the requirements of the research protocol

Related Conditions & MeSH terms

• Dysmenorrhea
• Menstrual Pain

Intervention

Other:
• Aerobic exercise
Individuals in this group will be given 8-week individualized exercise according to the Karvonen protocol (heart rate reserve percentage-% HR). Exercise training will be 30 minutes at 50% of HR between weeks 0-2, 45 minutes at 50% of HR between weeks 2-4, 45 minutes at 60% of HR between weeks 4-6 and 6-8 weeks It will be done on the treadmill 3 days a week, for 60 minutes at 60% of HR between weeks. The treadmill speed will be adjusted during exercise to maintain the set target heart rate level.
• Yoga exercise
Individuals in this group will be given 8-week individualized yoga exercise including stretching, relaxing, strength training. Exercise training will be done 3 days a week. The duration of the exercise will be adjusted to be the same as the aerobic exercise group.

Locations

Country	Name	City	State
Turkey	Gamze Nalan Çinar	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Arnold CM, Warkentin KD, Chilibeck PD, Magnus CR. The reliability and validity of handheld dynamometry for the measurement of lower-extremity muscle strength in older adults. J Strength Cond Res. 2010 Mar;24(3):815-24. doi: 10.1519/JSC.0b013e3181aa36b8. — View Citation

Bianco A, Lupo C, Alesi M, Spina S, Raccuglia M, Thomas E, Paoli A, Palma A. The sit up test to exhaustion as a test for muscular endurance evaluation. Springerplus. 2015 Jul 2;4:309. doi: 10.1186/s40064-015-1023-6. eCollection 2015. — View Citation

Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5. — View Citation

Guimaraes AC, Vaz MA, De Campos MI, Marantes R. The contribution of the rectus abdominis and rectus femoris in twelve selected abdominal exercises. An electromyographic study. J Sports Med Phys Fitness. 1991 Jun;31(2):222-30. — View Citation

Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6. — View Citation

Levine DW, Kripke DF, Kaplan RM, Lewis MA, Naughton MJ, Bowen DJ, Shumaker SA. Reliability and validity of the Women's Health Initiative Insomnia Rating Scale. Psychol Assess. 2003 Jun;15(2):137-48. doi: 10.1037/1040-3590.15.2.137. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. — View Citation

Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968 Nov-Dec;30(6):853-67. doi: 10.1097/00006842-196811000-00006. No abstract available. — View Citation

Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual pain severity	As primary outcome measures, the highest menstrual pain severity perceived by the participants in their last menstruation and the average of the pain severity in the first 3 days of their menstruation will be evaluated. A 10-cm VAS from zero (no pain at all) to 10 (the worst pain I have ever felt) will be used to determine the severity of menstrual pain. Individuals will be asked to mark the severity of pain they felt in the first 3 days of their last menstruation on 3 separate VAS lines.	Change in severity of menstrual pain from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Uterine artery blood flow	Determination of uterine artery blood flow changes will be made with Doppler US imaging device. Uterine arterial blood flow will be determined by recording the systole / diastole ratios (S / D), pulsatility indices (PI) and resistance indices (RI) values in the first 3 days of the menstrual cycle of individuals.	Change in uterine artery blood flow from baseline up to end of 8th week.
Secondary	Body mass index	Evaluation of body mass index will be done by weighing scale. Results will be presented in kg/m2.	Change in body mass index from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	body fat percentage	Evaluation of body fat percentage will be done by weighing scale. Results will be presented in %.	Change in body fat percentage from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	body fat amount	Evaluation of body fat amount will be done by weighing scale. Results will be presented in kg.	Change in body fat amount from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	lean body weight ratio	Evaluation of lean body weight ratio will be done by weighing scale. Results will be presented in %.	Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Lean body weight	Evaluation of lean body weight ratio will be done by weighing scale. Results will be presented in kg.	Change in lean body weight ratio from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Cardiovascular fitness	Cardiovascular fitness will be evaluated with the "6-minute walk test". For this test, which evaluates functional performance; Marking will be made at both starting points of a distance of 30 meters in the corridor. Individuals will be asked to walk for 6 minutes at the highest speed without running, and at the end of 6 minutes, the distance they walked will be recorded in meters. During the exercise test, vital signs such as blood pressure, heart rate, fatigue, shortness of breath, oxygen saturation of all individuals will be recorded before and immediately after the test.	Change in cardiovascular fitness from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Muscular static endurance	For the abdominal static endurance test, a board will be used to position the patient in 60º flexion. The subjects will be positioned with the trunk at 60°, the hips and knees flexed at 90°, and the hands on the opposite shoulders, leaning against the board. The board will be pulled back 10 cm and the patient will be asked to keep his isometric position as much as possible by contracting his abdominal muscles. As soon as the subject's body touches the board, the test will be terminated and the time to hold the position will be recorded in seconds. The test is continued for a maximum of 120 seconds and after 120 seconds the test will be stopped.	Change in muscular static endurance from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Muscular dynamic endurance	30 seconds sit-up test will be used for dynamic endurance. In the 30-second sit-up test, individuals will be asked to stand up to the level of the lower angle of the scapula and return to the starting position, with the knees flexed at 90 degrees, the hands on the back of the neck and the soles of the feet on the ground, with the command to start in the supine position to evaluate the dynamic endurance of the abdominal muscles. The exact and correct number of starts during 30 seconds will be recorded as the test score.	Change in muscular dynamic endurance from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Muscle strength (for lower extremity)	Dominant side knee extension strength for the lower extremity will be measured with the Nicholas Manual Muscle Tester.	Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Muscle strength (for upper extremity)	For upper extremity muscle strength, the grip strength of the dominant hand will be measured with a Hand grip dynamometer.	Change in muscular strength from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Flexibility	It will be evaluated with the sit-reach test. Individuals will be asked to perform maximum trunk flexion with both hands on top of each other in a long sitting position with legs straight. The distance between the tip of the hand and the board against the soles of the feet will be measured. The distance will be recorded in +/- centimeters (cm).	Change in flexibility from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Menstrual stress level	The complaints of individuals in the menstrual, premenstrual and intermenstrual periods will be evaluated in the Menstrual Distress Complaint List.	Change in menstrual stress level from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Anxiety/depressive symptom level	Anxiety and depressive symptom levels of individuals will be evaluated with the Depression Anxiety Stress Scale.	Change in anxiety/depressive symptom level from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Quality of life level	The quality of life of individuals will be evaluated with the World Health Organization Quality of Life Scale-Short Form. In the scale consisting of 5 subsections, each section score varies between 4 and 20. Higher scores indicate higher quality of life.	Change in quality of life level from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Sleep quality	Sleep quality of individuals will be evaluated with the Women's Health Initiative Insomnia Scale. The higher the score, the higher the degree of insomnia.	Change in sleep quality level from baseline up to end of 8th week, 3rd month, and 6th month.
Secondary	Perception of improvement	A 3-point Likert-type scale will be used to evaluate the subjective perception of improvement of individuals. An increase in the score indicates that the perception of improvement increases.	Change in perception of improvement from baseline up to end of 8th week, 3rd month, and 6th month..